The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Optibond Extra Universal.
| Device ID | K182162 |
| 510k Number | K182162 |
| Device Name: | OptiBond EXTRa Universal |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Kerr Corporation 1717 W. Collins Ave Orange, CA 92867 |
| Contact | Mohammad Saad Ansari |
| Correspondent | Ardrena Jackson Sybron Dental Specialties 1717 W. Collins Ave Orange, CA 92867 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-10 |
| Decision Date | 2018-11-07 |
| Summary: | summary |